Chronic, Intractable Pain of the Trunk and/or Lower LimbsDELIVERYNCT03277378
Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial
A study testing lead placement followed by BurstDR stimulation in people with Chronic, Intractable Pain of the Trunk and/or Lower Limbs, run by Abbott Medical Devices at 25 sites in 7 countries.
Trial summary
Prospective, multi-center, randomized, single blind study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic, Intractable Pain of the Trunk and/or Lower Limbs
- What is being tested?
- lead placement followed by BurstDR stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 25 sitesin 7 countries
- Study dates
- 22 Sep 2017to 12 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient indicated for Spinal Cord Stimulation therapy in accordance with the approved labeling.
- Patient's pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage.
- Patient has a baseline score on the Numerical Rating Scale ≥6 over the past 24 hours for 'average overall pain'specific to the area(s) of chronic pain that will be treated with spinal cord stimulation.
- Patient is considered by the Study Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions for Use.
- Patient is >18 years of age at the time of enrollment.
- Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits.
- Patient has signed and received a copy of the Ethical Committee/Independent Review Board approved informed consent.
Who cannot join
- Patient currently has a spinal cord stimulation system implanted.
- Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant).
- Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
- Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure)
- Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).
Trial locations and contacts
25 sites in 7 countries.
25 sites in 7 countries
United States13 sites
Rush University
Chicago, Illinois, 60612
Comprehensive Spine Institute
Clearwater, Florida, 33765
St. Mary's Hospital
Huntington, West Virginia, 25701
Kansas University Medical Center
Kansas City, Kansas, 66160
Advanced Pain Care
Las Vegas, Nevada, 89052
Florida Pain Institute
Merritt Island, Florida, 32953
Oregon Health & Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
Nevada Advanced Pain Specialists
Reno, Nevada, 89511
Jason Edward Pope, MD
Santa Rosa, California, 95403
Spinal Diagnostics
Tualatin, Oregon, 97062
Precision Spine Care
Tyler, Texas, 75701
National Pain Institute Winter Park
Winter Park, Florida, 32789
Germany4 sites
Sana Kliniken Duisburg Gm.bH
Duisburg, 47055
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf
Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie
Gera
Klinikum Nürnberg Sud
Nuremberg
Australia2 sites
Frankston Pain Management
Frankston
North Shore Private Hospital
Saint Leonards
Austria2 sites
Hospital Elisabethinen GmbH
Graz
Wilhelminenspital Wien
Vienna, 1160
Netherlands2 sites
Alrijne Ziekenhuis
Leiderdorp
Stichting Rijnstate Ziekenhuis - Velp
Velp
About this study
Official title: Randomized, Controlled, Single Blind, Prospective, Multicenter Study Evaluating Anatomic Versus Targeted Lead Placement for BurstDR Therapy During the Trial Evaluation Period. (DELIVERY)
Prospective, multi-center, randomized, single blind study
Read the detailed description
This clinical investigation compares success rates for anatomically placed leads to conventional, targeted lead placement for BurstDR™ during the trial evaluation period with the St Jude Medical™ Invisible Trial System. Subjects will be blinded to treatment group and randomized in a 1:1 ratio as follows:
Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
If the subject qualifies for permanent system implant according to pre-defined criteria after the initial trial evaluation period, the subject will exit the clinical investigation and continue their treatment per the physician's standard of care. Subjects who do not qualify for permanent system implant according to pre-defined criteria after the initial trial evaluation period may participate in an extended trial evaluation period, per physician discretion, during which they will be programmed with tonic stimulation. Subjects continuing to an extended trial evaluation period will be followed through the completion of the extended trial period. At the end of the extended trial evaluation period, subjects will exit the clinical investigation.
- Being tested
- lead placement followed by BurstDR stimulation
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lead placement followed by BurstDR stimulationDevice
Also called Spinal Cord Stimulation non-surgical Leads, Spinal Cord Stimulation Clinician Programmer, Spinal Cord Stimulation Patient Controller
lead placement followed by BurstDR stimulation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (AB) | Active comparator | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period Receives: Device: lead placement followed by BurstDR stimulation |
| Group 2 (TB) | Active comparator | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period Receives: Device: lead placement followed by BurstDR stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period
The primary endpoint is the qualification rate for permanent system implant at the end of the initial trial evaluation period.
Qualification for permanent system implant was defined by a composite where all the following conditions were met:
- ≥ 50% patient reported pain relief (PRP) at the end of the trial evaluation
- Trial evaluation period lasted for a minimum of 3 days
- Physician recommends subject for permanent system implant
- Subject reports a willingness to pursue a permanent system implant
Subjects did not qualify for permanent system implant if they met both of the following:
- < 50% PRP (patient reported pain relief) at the end of the trial evaluation
- Trial evaluation period lasted for a minimum of 5 days
Measured: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Secondary outcomes (1)
Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study
The physician preference for placement of leads was noted by giving them the option of choosing which lead placement technique they preferred - anatomic or targeted lead placement technique.
Measured: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start22 Sep 2017
- Primary completion23 Aug 2018
- Study completion12 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic, Intractable Pain of the Trunk and/or Lower LimbsStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robyn Capobianco, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277378
- Sponsor's protocol ID
- SJM-CIP-10116
- Acronym
- DELIVERY
- Status last verified
- Dec 2020
- First submitted
- 4 Sep 2017
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Single Blind, Prospective, Multicenter Study Evaluating Anatomic Versus Targeted Lead Placement for BurstDR Therapy During the Trial Evaluation Period. (DELIVERY)
- ClinicalTrials.gov ID
- NCT03277378
- Acronym / sponsor ID
- DELIVERY / SJM-CIP-10116
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 12 Oct 2018 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, randomized, single blind study
Detailed description
This clinical investigation compares success rates for anatomically placed leads to conventional, targeted lead placement for BurstDR™ during the trial evaluation period with the St Jude Medical™ Invisible Trial System. Subjects will be blinded to treatment group and randomized in a 1:1 ratio as follows:
Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
If the subject qualifies for permanent system implant according to pre-defined criteria after the initial trial evaluation period, the subject will exit the clinical investigation and continue their treatment per the physician's standard of care. Subjects who do not qualify for permanent system implant according to pre-defined criteria after the initial trial evaluation period may participate in an extended trial evaluation period, per physician discretion, during which they will be programmed with tonic stimulation. Subjects continuing to an extended trial evaluation period will be followed through the completion of the extended trial period. At the end of the extended trial evaluation period, subjects will exit the clinical investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (AB) | Active comparator | Device: lead placement followed by BurstDR stimulationGroup 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
| Group 2 (TB) | Active comparator | Device: lead placement followed by BurstDR stimulationGroup 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient indicated for Spinal Cord Stimulation therapy in accordance with the approved labeling.
- Patient's pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage.
- Patient has a baseline score on the Numerical Rating Scale ≥6 over the past 24 hours for 'average overall pain'specific to the area(s) of chronic pain that will be treated with spinal cord stimulation.
- Patient is considered by the Study Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions for Use.
- Patient is >18 years of age at the time of enrollment.
Key exclusion criteria (5 listed)
- Patient currently has a spinal cord stimulation system implanted.
- Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant).
- Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
- Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure)
- Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lead placement followed by BurstDR stimulationAlso: Spinal Cord Stimulation non-surgical Leads, Spinal Cord Stimulation Clinician Programmer, Spinal Cord Stimulation Patient Controllerlead placement followed by BurstDR stimulation | Device | Group 1 (AB), Group 2 (TB) |
Primary outcome
Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period
Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
The primary endpoint is the qualification rate for permanent system implant at the end of the initial trial evaluation period. Qualification for permanent system implant was defined by a composite where all the following conditions were met: * ≥ 50% patient reported pain relief (PRP) at the end of the trial evaluation * Trial evaluation period lasted for a minimum of 3 days * Physician recommends subject for permanent system implant * Subject reports a willingness to pursue a permanent system implant Subjects did not qualify for permanent system implant if they met both of the following: * < 50% PRP (patient reported pain relief) at the end of the trial evaluation * Trial evaluation period lasted for a minimum of 5 days
1 secondary outcome
Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study
Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn Capobianco, PhD study director
Abbott
25 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lead placement followed by BurstDR stimulation in people with Chronic, Intractable Pain of the Trunk and/or Lower Limbs, run by Abbott Medical Devices at 25 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Germany, Australia, Austria, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period (time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.